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Starting soon Not applicable

International Study on Treatment of Liver (HCC) Patients With IRE

NCT07192731 · tracked via the Priya Life Science UK tracker
Phase
Not applicable
Started
2026-02
Last updated
2025-10-10

Condition(s) studied

Hepatocellular Carcinoma (HCC)Liver AblationLiver Cancer, Adult

Investigational drug(s) / intervention(s)

Irreversible Electroporation

Irreversible Electroporation: Irreversible electroporation (IRE) is a procedure which involves the passage of short intense electrical pulses between probes to destabilize cell membranes by creating "nanopores" which leads to cell destabilisation and cell death. IRE can be used to selectively damage cancerous cells whilst sparing adjacent supporting connective tissue in vessels and bile ducts allowing a more targeted treatment compared to other types of ablation. IRE also avoids the heat-sink phenomenon which compromises the effectiveness of thermal ablation and possibly reduces the risks of biliary injury.

Study summary

Procedural data will be recorded from patients with liver lesions from hepatocellular cancer who have been assessed by an appropriately constituted MDT (or equivalent) as appropriate to receive irreversible electroporation

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients aged 18 years and over, able to provide informed consent and with clinical diagnosis of an HCC. Tissue confirmation of HCC prior to treatment is not standard of care and is therefore not required for this study. * Child-Pugh A up to A6. * Eastern Co-operative Oncology Group (ECOG) Score ≤ 2. * Rockwood Frailty Score ≤ 3. * Serum bilirubin \< 30 µmol/L. * Serum creatinine \< 150 µmol/L. * No extrahepatic metastases * IRE can be used for up to 3 tumours \< 3cm in size. Other forms of ablation can be combined with IRE in the same sitting but not for the same lesion. IRE can also be combined with surgical resection. Exclusion Criteria: General: * Patients involved in other research studies. * Patients under the age of 18 years. * Inability to give informed consent. * Patients who are pregnant. * Child-Pugh B or C. * Patients with an ECOG status of \> 2 at time of recruitment. * Rockwood Frailty Score \> 3 * Impaired renal function (serum creatinine \> 150 µmol/L) * Accepted exclusions to IRE from consensus criteria including: * Platelet count \< 50x109 U/L. * International normalised ratio (INR) for blood clotting \> 1.7. * Prior hepatic tumour ablation. Cardiovascular fitness related exclusions: * History of ventricular arrhythmia. * Implanted pacemaker or defibrillator. * Congestive cardiac failure NYHA Class ≥ 3. Tumour-related exclusions: * Tumour ≥ 3 cm in size. * Extrahepatic metastatic disease. * Jaundice (serum bilirubin \> 30 µmol/L). * MDT recommends use of thermal ablation for any given lesion.

Primary outcome measure(s)

  • Target Tumour Eradication — 6 months
    The percentage of target tumours successfully eradicated 6 months after the initial IRE procedure, according to RECIST and PERCIST criteria. This is based on a per-lesion analysis.

Trial sites (1)

FacilityCityRegionStatus
Manchester Royal Infirmiary Manchester United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07192731 on ClinicalTrials.gov ↗ ← All trials in the UK